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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH084674 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Texas | OTHER |
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The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version. Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) | Experimental | This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression. The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms. |
|
| Control-Standard Care | No Intervention | Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms. The participants in the control arm are followed and matched to a participant in the intervention arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT-AD) | Behavioral | CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a |
| MADRS and BDI-1a scores at 6 and 9-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Report Adherence | Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence. | Self-reported adherence at 6 and 9-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane M Simoni, Ph.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Familiar La Fe CARE Center | El Paso | Texas | 79925 | United States |
Eligible participants were randomly assigned to the intervention or treatment as usual (TAU) control condition, both enhanced with the notification letter to provider. An external statistician had used a computerized random number generator to select random permuted blocks of four.
Data were collected in a two-stage process from 10/21/2009 - 8/31/2011 at a publicly-funded community health clinic in El Paso, TX, on the U.S.-Mexico border.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy (CBT-AD) | CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions |
| FG001 | Control-Standard Care | Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy (CBT-AD) | CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a |
| Posted | Mean | Standard Deviation | Units on a scale | MADRS and BDI-1a scores at 6 and 9-month follow-up |
|
1 Year, 9 Months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-Behavioral Therapy (CBT-AD) | CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John A. Sauceda | University of California, San Francisco | 415-460-6045 | john.sauceda@ucsf.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| MedSignals Electronic Pill-box for Adherence |
The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication. |
| 6 and 9 month follow-up adherence scores |
| BG001 | Control-Standard Care | Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Beck Depression Inventory 1a | Self-reported depressive symptoms were assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. | Mean | Standard Deviation | units on a scale |
|
| Visual Analog Scale 30-day Adherence | Self-reported adherence was assessed with the visual analog scale. This is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence. | Mean | Standard Deviation | Percent of doses taken |
|
| Electronic Drug Adherence Monitoring | The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding the designated time of taking their medication. | Mean | Standard Deviation | Percent Adherence |
|
| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The scale was developed to capture current depressive symptoms within the past seven days. The areas covered include: apparent and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Description |
|---|
| OG000 | Cognitive-Behavioral Therapy (CBT-AD) | CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session. Cognitive-Behavioral Therapy AD: Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions |
| OG001 | Control-Standard Care | Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm. |
|
|
| Secondary | Self-Report Adherence | Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence. | Posted | Mean | Standard Deviation | Percent of all doses of medication taken | Self-reported adherence at 6 and 9-month follow-up |
|
|
|
| Secondary | MedSignals Electronic Pill-box for Adherence | The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication. | Posted | Mean | Standard Deviation | Percent adherence | 6 and 9 month follow-up adherence scores |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control-Standard Care | Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm. | 0 | 20 | 0 | 20 |
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| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |